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NCT04142320 · ClinicalTrials.gov registry record · NA

Closed-loop Optimized rTMS for Depression

A NA study of Major Depressive Disorder, sponsored by Stanford University.

Recruiting
Registry status
NA
Development phase
54
Enrollment target
1
Study location

NCT04142320 is a NA study of Major Depressive Disorder that is actively recruiting participants, run by Stanford University. The registered enrollment target is 54 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04142320, a NA study of Major Depressive Disorder, is actively recruiting participants, sponsored by Stanford University.

RECRUITING
Registry status
NA
Development phase
54 participants
Enrollment target
1
Study location

Study Summary

Targeted and individualized treatments for mental health disorders are critically needed. Repetitive transcranial magnetic stimulation (rTMS) represents the front-line of new and innovative approaches to normalizing dysfunctional brain networks in those with mental illness. rTMS is FDA-approved for depression and obsessive-compulsive disorder with clinical trials underway for PTSD and addiction, among others. However, remission rates are suboptimal and ideal stimulation parameters are unknown. We recently completed a randomized, double blind clinical trial and a depression severity biomarker that predicts clinical outcome. The overarching goal of this study is to develop the first broadly generalizable platform for real-time biomarker monitoring and personalized rTMS treatment. We plan to recruit patients with medication-resistant depression and in perform a four-phase, cross-over, double-blind, placebo-controlled trial to 1) identify how standard and optimized rTMS patterns engage the depression severity biomarker, and 2) determine the dose-response of these rTMS patterns. Findings from this study will provide the basis for a double-blind, randomized clinical trial comparing rTMS optimized to the individual against standard rTMS.

Conditions Studied

Interventions

  • DEVICE sham rTMS
  • DEVICE closed-loop rTMS
  • DEVICE open-loop rTMS

Study Locations (1)

California

  • Stanford University - Stanford

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2021-06-01
Est. Completion 2025-12-01
Phase NA

Sponsor

Stanford University

1,744 total trials

What the Registry Record Tells You About NCT04142320

The ClinicalTrials.gov registry entry for NCT04142320 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (86% lower). The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 3 interventions - of which sham rTMS is the first listed.

NCT04142320 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT04142320 about?

NCT04142320 is a clinical study titled "Closed-loop Optimized rTMS for Depression". Targeted and individualized treatments for mental health disorders are critically needed. Repetitive transcranial magnetic stimulation (rTMS) represents the front-line of new and innovative approaches to normalizing dysfunctional brain networks in those with mental illness. rTMS is FDA-approved for ...

What is the current status of trial NCT04142320?

This trial is currently recruiting. It is a NA study. The enrollment target is 54 participants. The study started on 2021-06-01. Estimated completion is 2025-12-01.

What conditions does trial NCT04142320 study?

This clinical trial studies the following conditions: Major Depressive Disorder.

What interventions are being tested in trial NCT04142320?

The interventions under investigation include: sham rTMS (DEVICE), closed-loop rTMS (DEVICE), open-loop rTMS (DEVICE).

Who is sponsoring clinical trial NCT04142320?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04142320 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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